Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement

Johnathan H Goree; Stuart A Grant; David M Dickerson; Brian M Ilfeld; Yashar Eshraghi; Sandeep Vaid; Ali K Valimahomed; Jarna R Shah; G Lawson Smith; John J Finneran; Nirav N Shah; Maged N Guirguis; Maxim S Eckmann; Ajay B Antony; Brian J Ohlendorf; Mayank Gupta; John E Gilbert; Amorn Wongsarnpigoon; Joseph W Boggs

doi:10.1016/j.neurom.2024.03.001

Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement

Neuromodulation. 2024 May 10:S1094-7159(24)00064-3. doi: 10.1016/j.neurom.2024.03.001. Online ahead of print.

Authors

Johnathan H Goree¹, Stuart A Grant², David M Dickerson³, Brian M Ilfeld⁴, Yashar Eshraghi⁵, Sandeep Vaid⁶, Ali K Valimahomed⁷, Jarna R Shah⁸, G Lawson Smith⁸, John J Finneran⁴, Nirav N Shah³, Maged N Guirguis⁵, Maxim S Eckmann⁹, Ajay B Antony¹⁰, Brian J Ohlendorf¹¹, Mayank Gupta¹², John E Gilbert¹³, Amorn Wongsarnpigoon¹³, Joseph W Boggs¹³

Affiliations

¹ Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA. Electronic address: JHGoree@uams.edu.
² Department of Anesthesiology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
³ Department of Anesthesiology, Critical Care, and Pain Medicine, Endeavor Health, Evanston, IL, USA; The University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.
⁴ Department of Anesthesiology, University of California San Diego, La Jolla, CA, USA.
⁵ Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA, USA.
⁶ Better Health Clinical Research, Newnan, GA, USA.
⁷ Grammercy Pain Center, Holmdel, NJ, USA.
⁸ Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
⁹ Department of Anesthesiology, University of Texas San Antonio, San Antonio, TX, USA.
¹⁰ The Orthopedic Institute, Gainesville, FL, USA.
¹¹ Department of Anesthesiology, Duke University Hospital, Durham, NC, USA.
¹² Neuroscience Research Center, Overland Park, KS, USA.
¹³ SPR Therapeutics, Cleveland, OH, USA.

PMID: 38739062
DOI: 10.1016/j.neurom.2024.03.001

Abstract

Objectives: Total knee arthroplasty (TKA) is an effective surgery for end-stage knee osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, but percutaneous peripheral nerve stimulation (PNS) is a promising nonopioid treatment option for chronic, persistent postoperative pain. The objective of the present study was to evaluate the effect of a 60-day percutaneous PNS treatment in a multicenter, randomized, double-blind, placebo-controlled trial for treating persistent postoperative pain after TKA.

Materials and methods: Patients with postoperative pain after knee replacement were screened for this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects in both groups underwent ultrasound-guided placement of percutaneous fine-wire coiled leads targeting the femoral and sciatic nerves on the leg with postoperative pain. Leads were indwelling for eight weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ≥50% reduction in average pain relative to baseline during weeks five to eight. Functional outcomes (6-minute walk test; 6MWT and Western Ontario and McMaster Universities Osteoarthritis Index) and quality of life (Patient Global Impression of Change) also were evaluated at end of treatment (EOT).

Results: A greater proportion of subjects in the PNS groups (60%; 12/20) than in the placebo (sham) group (24%; 5/21) responded with ≥50% pain relief relative to baseline (p = 0.028) during the primary endpoint (weeks 5-8). Subjects in the PNS group also walked a significantly greater distance at EOT than did those in the placebo (sham) group (6MWT; +47% vs -9% change from baseline; p = 0.048, n = 18 vs n = 20 completed the test, respectively). Prospective follow-up to 12 months is ongoing.

Conclusions: This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.

Keywords: Chronic pain; neurostimulation; percutaneous peripheral nerve stimulation; peripheral nerve stimulation; total knee arthroplasty.